U.S. patent application number 11/223530 was filed with the patent office on 2006-01-12 for dynamic fixation device and method of use.
Invention is credited to Stephen Ritland.
Application Number | 20060009768 11/223530 |
Document ID | / |
Family ID | 33158501 |
Filed Date | 2006-01-12 |
United States Patent
Application |
20060009768 |
Kind Code |
A1 |
Ritland; Stephen |
January 12, 2006 |
Dynamic fixation device and method of use
Abstract
A dynamic fixation device is provided that allows the vertebrae
to which it is attached to move in flexion within the normal
physiological limits of motion, while also providing structural
support that limits the amount of translation motion beyond normal
physiological limits. The present invention includes a flexible
portion and two ends that are adapted for connection to pedicle
screws.
Inventors: |
Ritland; Stephen;
(Flagstaff, AZ) |
Correspondence
Address: |
SHERIDAN ROSS PC
1560 BROADWAY
SUITE 1200
DENVER
CO
80202
US
|
Family ID: |
33158501 |
Appl. No.: |
11/223530 |
Filed: |
September 9, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10406895 |
Apr 4, 2003 |
6966910 |
|
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11223530 |
Sep 9, 2005 |
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60370708 |
Apr 5, 2002 |
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Current U.S.
Class: |
606/254 ;
606/261; 606/907 |
Current CPC
Class: |
A61B 17/7001 20130101;
A61B 17/7004 20130101; A61B 17/701 20130101; A61B 17/7011 20130101;
A61B 17/7026 20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61B 17/56 20060101
A61B017/56 |
Claims
1. An implant device for flexibly linking at least two vertebra of
a spine of a patient, comprising: a rod portion including a first
end having a first cross-sectional area, a second end having a
second cross-section area, and a first center section disposed
between said first end and said second end, said first center
section having a smaller cross-sectional area than at least one of
either said first cross-sectional area or said second
cross-sectional area; and means for connecting said rod portion to
the spine of the patient; wherein said first center section flexes
when the patient bends their spine.
2. The device as claimed in claim 1, further comprising a second
center section disposed between said first end and said second end,
said second center section also having a smaller cross-sectional
area than at least one of either said first end or said second
end.
3. The device as claimed in claim 1, wherein said first center
section has a cross-sectional area shape selected from the group
consisting of elongated ellipse, flattened rectangle, flattened
hexagon, circular, and cresent.
4. The device as claimed in claim 2, wherein either said first
center section or said second center section comprises an inverted
T-shape.
5. The device as claimed in claim 2, wherein either said first
center section or said second center section comprises an arcuate
shape.
6. The device as claimed in claim 1, wherein said means for
connecting comprises at least one rod connector and at least one
pedicle screw.
7. The device as claimed in claim 1, wherein said device comprises
a metal alloy.
8. The device as claimed in claim 1, wherein said device comprises
titanium.
9. The device as claimed in claim 1, wherein said device comprises
stainless steel.
10. An implant device for flexibly linking at least two vertebra of
a spine of a patient, comprising: a rod having a first end and
second end; a flexible portion positioned between said first end
and said second end, said flexible portion including an inverted
T-shaped region comprising a first pair of reverse bends and a
second pair of reverse bends.
11. The implant device as claimed in claim 10, wherein said first
pair of reverse bends is at an angle of greater than about 135
degrees.
12. The implant device as claimed in claim 11, wherein said second
pair of reverse bends is at an angle of greater than about 135
degrees.
13. The device as claimed in claim 10, wherein said implant device
comprises a metal alloy.
14. The device as claimed in claim 10, wherein said implant device
comprises titanium.
15. The device as claimed in claim 10, wherein said implant device
comprises stainless steel.
16. In subcombination, an intervertebral bridge linkage device for
flexibly fixating a first vertebra of a patient's spine to a second
vertebra of the patient's spine, the linkage used in combination
with a first connector mechanism and a first pedicle screw for
interconnecting the linkage to the first vertebra, and a second
connector mechanism and a second pedicle screw for interconnecting
the linkage to the second vertebra, the linkage device comprising:
a rod portion including a first end having a first cross-sectional
area, a second end having a second cross-section area, and a first
center section disposed between said first end and said second end,
said first center section having a smaller cross-sectional area
than at least one of either said first cross-sectional area or said
second cross-sectional area; wherein said first center section
flexes when the patient bends their spine.
17. The subcombination as claimed in claim 16, wherein said center
section further comprises an inverted T-shaped region comprising a
first pair of reverse bends and a second pair of reverse bends.
18. The subcombination as claimed in claim 17, wherein said first
pair of reverse bends is at an angle of greater than about 135
degrees.
19. The subcombination as claimed in claim 18, wherein said second
pair of reverse bends is at an angle of greater than about 135
degrees.
20. The subcombination as claimed in claim 16, wherein said rod
portion comprises a metal alloy.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] Priority is claimed from U.S. Provisional Patent Application
No. 60/370,708 filed Apr. 5, 2002 entitled "Dynamic Fusion System"
which is incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] This invention relates generally to securement devices and,
more particularly, to a flexible rod or device along a portion
thereof that is capable of flexibly securing vertebrae
together.
BACKGROUND OF THE INVENTION
[0003] The lumbar spine absorbs a remarkable amount of stress and
motion during normal activity. For the majority of the population,
the healing response of the body is able to stay ahead of the
cumulative effects of injury, wear, and aging, and yet still
maintain stability with reasonable function. In some cases,
however, the trauma or stress exceeds the ability of the body to
heal, leading to local breakdown and excessive wear, and frequently
also leads to local instability. Accordingly, degenerative change
with age superimposed on baseline anatomy in the lumbar spine lead
to problems including instability, pain and neurologic compromise
in some patients. In some cases, the local anatomy may not provide
the same protection to the motion segment, thereby aggravating this
breakdown. Although rehabilitation, conditioning, the limitation of
stress, and time to recover are effective treatments for most
patients, there is a significant failure rate with persistent pain,
disability and potential neurologic deficit.
[0004] Referring now to FIGS. 1, and 2, two side views of a pair of
adjacent vertebral bodies are shown. FIG. 1 illustrates two
vertebra V.sub.1 and V.sub.2 of the spine in a neutral position. As
shown in FIG. 2, when a person leans forwards, the spine undergoes
flexion. The anterior portion of the spine comprises a set of
generally cylindrically shaped bones which are stacked one on top
of the other. These portions of the vertebrae are referred to as
the vertebral bodies VB.sub.1 and VB.sub.2, and are each separated
from the other by the intervertebral discs D. The pedicles P.sub.1
and P.sub.2 comprise bone bridges which couple the anterior
vertebral body VB to the posterior portion of each vertebra. At
each intervertebral joint or disc D, flexion involves a combination
of anterior sagittal rotation and a small amplitude anterior
translation.
[0005] The intervertebral joint is a complex structure comprising
an intervertebral disk anteriorly, and paired zygapophyseal joints
posteriorly. The disk functions as an elastic support and
connection between the vertebra, and allows for flexion and
extension of the spine, as well as limited rotation and
translation. The zygapophyseal joints and associated anatomy allow
for significant flexion and extension while providing constraints
in translation and rotation.
[0006] The primary bending motion in the lumbar spine is flexion
and extension in an anterior/posterior plane. This occurs in the
range approximating 10-15 degrees of flexion and extension. In a
young or normal lumbar spine, this motion occurs about an axis in
the mid to posterior portion of the disk. This is associated with a
distraction or subluxation of the facet joints or posterior
elements of 10-15 mm. This occurs not about a pure axis, but about
a neutral zone, or a centroid of rotation associated with the
lumbar disk. The normal elasticity of the disk, joints and
ligaments, and the degree of play or freedom associated with these
joints, as well as the nature of the loads applied to the spine
contribute to the size of this region of rotation. In some cases,
the recurrent loads and motion on the disk and associated trauma to
disk and motion segment exceed the natural rate of healing or
repair of the body. In this situation, there is breakdown in the
motion segment associated with loss of the normal axis of rotation.
As increasing subluxation occurs with segmental motion, there is a
dramatic shift in the axis of rotation with displacement occurring
within the disk space or frequently to some point outside of the
disk. Therefore, in the situation of a failing motion segment,
there is breakdown in the centroid of rotation with associated
translation of the vertebral segments. This translation is allowed
by both breakdown occurring in the disk and instability associated
with both wear and degeneration of the zygapophyseal joints. The
underlying anatomy of the motion segment and joints allows for
significantly greater stress on the disc and contributes to
degeneration both in the disk and joints.
[0007] Traditionally, surgical treatment has been directed at
treating neural compromise, or if the pain, instability, or risk of
instability is considered sufficient, a segmental fusion has been
considered. More recently, stabilization procedures have been tried
over the past several years including artificial disks and
ligaments and elastomeric constructs to protect the spine.
Arthroplasty techniques to maximize function and reduce the dynamic
effects on adjacent segments are a more recent approach with less
follow-up as to long-term results. A challenge in designing such a
system is constraining motion in a normal physiologic range.
[0008] Current spinal fixation systems offer several drawbacks.
Rigid fusion constructs do not allow relative movement between the
vertebrae that are fused using a construct comprising a pedicle
screw, connector mechanism, and rigid rod. Furthermore, rigid
implants are known to create significant amounts of stress on the
components of the construct, including the pedicle screws and the
rod, as well as the bone structure itself. These stresses may even
cause the rigid rod to break. In addition, the stresses transferred
to the pedicle screws may cause the screws to loosen or even
dislodge from the vertebrae, thereby causing additional bone
damage.
[0009] Spinal fusion surgery is a method of fusing at least two
mobile segments of the spine to knit them together as one unit and
eliminate motion between the segments. A dynamic fixation device is
a quasi-flexible, semi-rigid fixation construct that allows some
measure of motion between the vertebrae attached to the dynamic
fixation device. Dynamic fixation of the lumbar spine provides
means of protecting lumbar structures and allows for healing
without proceeding to a lumbar arthrodesis. The constraints on such
a system are in some ways different than for a rigid or near rigid
construct, such as that used for fusion.
[0010] At the present time, pedicle fixation is an accepted method
of fixing to the spine. In the situation of a lumbar fusion, a
relatively rigid construct is appropriate to stabilize the spine
and allow healing of the bony structures. In the situation of
providing protection to the lumbar structures, a flexible system is
appropriate to limit but not stop the motion of lumbar elements.
The flexible elements in such a system need to accomplish several
objectives. The primary objective is to allow physiologic motion of
the spine, while protecting against excessive or non-physiologic
movement. A secondary consideration is to protect the pedicle
fixation from undue stress that could loosen the fixation at its
bony interface.
[0011] Artificial disks may replace a failing disk and approximate
a normal centroid or axis of rotation; however, placement of such a
device is technically demanding and replaces the normal disk with a
mechanical replacement with uncertain long-term results. The
artificial disk will be subject to wear without the healing
potential of the body to heal itself.
[0012] It is also desirable with some patients to have a spinal
implant system that allows the vertebral column to settle naturally
under the weight of the human body. Human bone heals more readily
under some pressure. In a rigid spinal implant system, the
patient's spinal column may be unnaturally held apart by the
structure of the implant. It is possible that this stretching of
the vertebrae, in relation to one another, results in delayed or
incomplete healing of the bone.
[0013] Posterior devices placed with pedicle fixation may provide
some stabilization, however, the natural motion of such devices
does not necessarily act to mimic normal physiology. In a healthy
lumbar spine the axis of rotation or neutral area for motion is
situated near the inferior posterior third of the lumbar disk. A
desirable artificial system would closely approximate physiologic
motion. However, to date, posterior systems have failed to address
these concerns.
[0014] Several existing patents disclose fusion devices having at
least some partial ability to flex. For example, U.S. Pat. No.
5,415,661 discloses a device that includes a curvilinear rod. The
curvilinear shape is designed to provide a specified amount of
flexibility, such that the implant supposedly restores normal
biomechanical function to the vertebrae of the spine receiving the
implant. However, the '661 patent does not disclose a device having
structure other than a curvilinear shape that has a radius of
curvature of between 0 to 180 degrees. In addition, the '661 patent
does not disclose the concept of providing an anteriorly projected
pivot point that models the natural articulation of the subject
vertebrae by using a structure that provides a virtual rotation
zone substantially identical to the rotation zone provided by the
patient's vertebrae. In addition, as seen in FIG. 3 of the '661
patent, the device disclosed in the '661 patent utilizes a body 4
having a central section 10 having an anteriorly oriented position
relative to its ends 6a, 6b.
[0015] U.S. Pat. No. 6,293,949 also discloses a flexible spinal
stabilization device that includes a longitudinal portion that
includes a series of shapes that have an accordion appearance. The
device disclosed in the '949 patent is intended for use along the
cervical vertebrae, and it is intended to be installed along the
anterior side of the vertebrae.
[0016] U.S. Pat. No. 6,440,169 discloses a device that attaches to
the spinous processes of two vertebrae and has a leaf spring that
allows the device to compress and then recover spontaneously after
the stress has ceased. However, the '169 patent does not address a
construct that includes an anteriorly projected pivot point that
allows the vertebrae to articulate when the spine undergoes
flexion.
[0017] In view of the above, there is a long felt but unsolved need
for a method and system that avoids the above-mentioned
deficiencies of the prior art and that provides an effective system
that is relatively simple to employ and requires minimal
displacement or removal of bodily tissue.
SUMMARY OF THE INVENTION
[0018] The present invention provides a device that can be
implanted and that provides for a specified amount of forward
bending motion, thereby allowing anterior sagittal rotation between
the vertebrae that receive the implant. Reference is hereby made
for the incorporation of the conventional descriptive terms of
motion and other content presented in Clinical Anatomy of the
Lumbar Spine and Sacrum by Nikolai Bogduk, third edition, published
by Churchill Livingstone, 1999. Although anterior sagittal rotation
or flexion between vertebrae is normal, significant anterior
sagittal translation or sliding motion between vertebrae is not.
Thus, by allowing some amount of rotational motion while protecting
against translation, the patient's condition or injury can be
protected, thus promoting the healing process, while subsequently
providing some ability to rotate one vertebra relative to an
adjacent vertebra, thereby allowing for improved spinal motion
following surgery and recovery. Accordingly, as described herein,
various implants, including a number of rod configurations having
flexible portions are presented that provide a device having the
ability to elongate and bend. Thus, it is a first aspect of the
present invention to provide a device that elongates, and a second
aspect of the present invention to provide a device that bends.
More particularly, present invention is a dynamic fixation device
that includes a flexible rod portion, wherein the flexible rod
portion can include one or more of the following: a thin section of
rod, a curvilinear rod portion, a geometric shape, and a hinge
portion. These dynamic fixation devices are constructed of a
material of an appropriate size, geometry, and having mechanical
properties such that they bend, thus allowing the vertebrae
associated with the implant to rotate relative to one another,
similar to the movement of a natural spine.
[0019] The normal instantaneous axis of rotation of the lumbar
spine occurs typically near the lower posterior third of the disk.
Conventional pedicle fixation of the spine typically places the
fixation rod or plate at the dorsal aspect of the apophyseal joint
or posterior to the joint. Therefore, it is appropriate to consider
a construct that effectively shifts this rotation point anteriorly
toward the physiologic axis.
[0020] A group of geometries exist, which if applied to a posterior
device, will constrain the subluxation of the segment and maintain
the rotation in or close to the normal zone or axis of rotation.
The indication for use is to constrain the stresses and motion
within a range which will allow the body's normal healing response
to maintain adequate competence in the motion segment to avoid
development of instability or neurologic deficit and minimize pain
or arthritis. The important features allow for maintenance of
physiologic motion without the abnormal subluxation or translation
that are associated with a degenerating disk and contribute to
further degeneration. Thus, it is a separate aspect of the
invention to provide a construct that limits excessive subluxation
or translation.
[0021] Although the motion is complex related to the range of
stresses which may be applied, it is nonetheless possible to
provide a device so that while in compression, movement is axial or
accompanied by slight dorsal translation, and that while in flexion
allows both separation of posterior elements and slight ventral
translation allowing rotation about the posterior portion of the
disk.
[0022] Accordingly, it is an aspect of the present invention to
provide a device that allows for some limited motion, thereby
decreasing the stresses placed on the various component parts of
the implant, as well as the affected vertebrae. It is a further
aspect of the present invention to provide a device whose motion is
designed to model the bending motion of the spine. Several separate
embodiments of the present invention accomplish such tasks.
[0023] It is a separate aspect of the present invention to provide
a construct that geometrically accommodates the human spinal
anatomy, while providing a structural member that provides an
anteriorly projected zone of rotation.
[0024] In a first embodiment, an implantable elastomeric material
may be used, or a surgically implantable alloy can be used that is
appropriately shaped and thinned to function as a spring and/or
pivot. Appropriate shaping and contouring the flexible rod portion
allows the flexible rod portion material to function in its elastic
range and avoid stress failure. Additionally, this aspect of the
invention allows control of how the motion occurs. More
particularly, this feature provides a virtual axis of rotation not
necessarily centered at the rod, thereby allowing the implant to
more closely approximate the normal physiology of the spine. Thus,
in the first embodiment provided herein, thinning and/or flattening
a rod will allow simple flexion to occur. As the flattened segment
is lengthened, progressively more translation may be allowed.
[0025] In a second embodiment presented herein, use of a more
complex curve on the flexible rod portion allows both flexion and
controlled translation, as well as axial settling in the event of
an axial load on the spine. Controlling areas of thinning along the
curve allows for controlling how the flexible rod portion bends
when loaded. In addition, variable adjustment of thinning along the
curve provides the ability to control translation, and thereby fine
tuning of the effective axis of rotation. Furthermore, creating a
curved rather than flat section allows for modification capability
to selectively vary the bending characteristics in flexion versus
extension, thus allowing a physician to control segmental
shifts.
[0026] In yet a separate embodiment, a double center section is
used to provide additional control of rotation, or allow for
translation without rotation. The double center section includes a
arcuate member and an inverted T-shaped member. The members are
appropriately thinned or flattened sufficiently to allow controlled
bending in flexion. Thus, the dual members may take on a variety of
different shapes to achieve the appropriate bending
characteristics.
[0027] For the above described devices, first and second rod arms
are attached to either end of the flexible construct, with the
other end of the rod arms attached to connectors, which in turn are
connected to pedicle screws that are inserted into vertebrae of the
spine. During flexion and extension each vertebra exhibits an
arcuate motion in relation to the vertebra below. The center of the
arc lies below the moving vertebra. The dynamic fusion device
provides a device for allowing movement of the vertebrae, with a
forwardly or anteriorly projected pivot location that models and
substantially aligns with the actual pivot point of rotation for
the vertebrae to which the device is attached. Accordingly, the
dynamic fusion device provides a bendable rod for fusion that
mimics the movement of the vertebrae of the spine.
[0028] The dynamic portions of the various embodiments of the
present invention lengthen as they are elongated and shorten as
they compressed. This characteristic allows the devices to be
implanted in the spine with a pedicle screw system, and while the
actual construct is positioned well dorsal in the spine, it will
allow the spine to function as though there were a flexible
construct in the anterior column of the spine.
[0029] In use, a problematic spinal disc is initially identified by
a physician. During surgery, an incision is made through the skin
and muscle overlying the implant location of the spine. Then a
first pedicle screw is inserted into a first vertebra and a second
pedicle screw is inserted into a second vertebra. The surgeon then
attaches the dynamic fixation device to the pedicle screws using
either an adjustable connector or an end connector that is
integrally formed as a part of the dynamic fixation device.
[0030] Additional advantages of the present invention will become
readily apparent from the following discussion, particularly when
taken together with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] FIG. 1 is a side perspective view of two vertebra in a
neutral position;
[0032] FIG. 2 is a side perspective view of the two vertebra shown
in FIG. 1 in a condition of flexion;
[0033] FIG. 3 is a side elevation view of a first embodiment of a
dynamic fixation device used in conjunction with pedicle
screws;
[0034] FIG. 4 is a cross-sectional view of a first end of the rod
portion of the device shown in FIG. 3;
[0035] FIG. 5 is a side elevation view of a modified version of the
first embodiment shown in FIG. 3;
[0036] FIG. 6 is a side elevation view of a yet a different
modified version of the first embodiment shown in FIG. 3;
[0037] FIG. 7 is a side elevation view of still a yet a different
modified version of the first embodiment shown in FIG. 3;
[0038] FIGS. 8a-8h depict cross-sectional views of various
potential center sections;
[0039] FIG. 9 illustrates a separate embodiment of a dynamic
fixation device;
[0040] FIG. 10 illustrates a separate embodiment of a dynamic
fixation device; and
[0041] FIGS. 11a-11f depict cross-sectional views of various
potential center sections.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0042] While the present invention will be described more fully
hereinafter with reference to the accompanying drawings, in which
particular embodiments and methods of implantation are shown, it is
to be understood at the outset that persons skilled in the art may
modify the invention herein described while achieving the functions
and results of this invention. Accordingly, the descriptions which
follow are to be understood as illustrative and exemplary of
specific structures, aspects and features within the broad scope of
the present invention and not as limiting of such broad scope.
[0043] As noted above, at each intervertebral joint or disc D,
flexion involves a combination of anterior sagittal rotation and a
small amplitude anterior translation. The various embodiments of
the present invention allow for controlled rotation while limiting
translation within an acceptable, normal physiological range.
[0044] Referring now to FIG. 3, a first embodiment of a dynamic
fixation system 1 is illustrated. The dynamic fixation device 1
includes a rod portion 10 having a first end 12, a center section
14, and a second end 16. First end 12 and second end 16 of rod
portion 10 are preferably connected to connectors 18a, 18b that, in
turn, are connected to pedicle screws 20, where pedicle screws 20,
shown in dashed lines, are inserted into the pedicles of vertebrae
when the device is used to fixate vertebrae. In one example of this
embodiment, as shown in FIG. 3, rod portion 10 is interconnected at
first end 12 to connector 18a. Connector 18a located at first end
12 is of the type that is integrally formed as part of rod portion
10. Alternately, a connector may be a separate type of connector
that can be selectively positioned along the length of rod portion
10. For example, connector 18b at second end 16 of rod portion 10
is selectively adjustable and may be interconnected to rod portion
10 at a plurality of positions along second end 16 by slidably
adjusting the location of second end 16 within band 17 of connector
18b prior to tightening of connector 18b to interlock the position
of second end 16 within connector 18b.
[0045] The center section 14 may have a constant cross-sectional
area as shown in FIG. 3. Alternately, as shown in FIG. 3, the
cross-section may vary along the length of rod portion 10. FIG. 3
shows the rod portion 10 having a center section 14 with a smaller
cross-sectional width than the cross-sectional width of rod portion
10 at first end 12 or second end 16. In one example of this
embodiment, rod portion 10 has a circular cross-section at first
end 12 and a circular cross-section at second end 16. FIG. 4
depicts one possible cross-section of rod portion 10 at first end
12. As shown in FIG. 3, this is the same cross-section as that
located at second end 16, and is typically about 5 mm in
diameter.
[0046] Referring now to FIG. 5, dynamic fixation device 1'
illustrates a modification of the first embodiment wherein the
cross-sectional area varies along the length of center section 14
between first end 12 and second end 16. As shown in FIG. 5, a
continuously varying cross-sectional area may be used wherein the
cross-sectional profile varies continuously along the length of
center section 14. More specifically, FIG. 5 depicts one example of
this modification to the first embodiment wherein the width of the
center section varies from its widest diameter at first end 12
and/or second end 16, and gradually thins to about the center of
center section 14.
[0047] Referring now to FIG. 6, the cross-sectional profile of
center section 14 may vary at discrete points. FIG. 6 depicts yet a
different modification of the first embodiment. Dynamic fixation
device 1''' illustrates an example of such a variable profile,
wherein a stepwise variable cross-sectional area is provided along
center section 14. As shown in FIG. 6, center section 14 can
include a first width at first end 12 and second end 16, a second
width at intermediate region 21, and a third width at center region
22.
[0048] Referring now to FIG. 7, in yet an alternate modification,
dynamic fixation device 1.sup.IV includes a center section 14 that
resembles a twisting ribbon. Center section 14 can be uniform or
variable in its width, and is twisted along its length.
[0049] The above described alternative configurations offer
different bending characteristics, such as the ability to allow a
measure of twisting rotation as opposed to only pure bending.
Depending upon a patient's circumstances, the attending physician
may desire incorporating an implant with one of these different
profiles to provide dynamic fixation of the patient's
vertebrae.
[0050] Referring now to FIGS. 8a-8h, without limitation, the
cross-section of center section 14 of rod portion 10 can be of a
number of different shapes, and those shapes may vary in
cross-sectional area. Preferably, center section 14 has a thickness
of about 2 to 3 mm, with a width of about 5 mm. However, the
dimensions will vary depending upon the specific design necessary
for a specific patient. More particularly, the dimensions of center
section 14 will likely be thicker for a large heavy man, as opposed
to that needed for a small petite woman. Furthermore, the type of
material used to construct center section 14 will also impact the
required dimensions of center section 14. Rod portion 10 can be
made of a variety of materials, preferably metals or materials
demonstrating resilient characteristics, and more preferably, a
titanium alloy or surgical stainless steel. In addition,
combinations or layers of materials may be used. For example,
center section 14 can be formed within its center of material(s)
having resilient or rubber like qualities, with a flexible metallic
wrapping sufficiently thick to substantially resist translational
motion. Such a configuration allows rotational bending and
elongation during flexion while preventing the discs from exceeding
normal physiologic limits of translational motion. Since different
materials have different strength and resilient properties, the
type of material used will, in part, dictate the dimensions of the
rod portion required to achieve a certain function in a specific
patient.
[0051] As shown in FIG. 8a, the cross-section of center section 14
of rod portion 10 may be that of an elongated ellipse. Alternately,
as shown in FIG. 8b, the cross-section of center section 14 may be
that of a flattened rectangle. In yet an alternate variation, the
center section 14 may resemble a bow-tie, as shown in FIG. 8c, or a
flattened hexagon as shown in FIG. 8d. FIG. 8e depicts a center
section 14 having a circular cross-section, but one that is
sufficiently small such that is provides the ability to flex or
bend. FIGS. 8f-8h depict cross-sections with variable widths, a
feature shared with the structure shown in FIG. 8c. FIG. 8h is a
crescent shaped center section 14. Therefore, center section 14 can
be of a variety of different shapes and yet still provide the
necessary flexibility to allow for controlled, limited bending of
the spine.
[0052] Appropriate shaping and contouring of the center section 14
allows rod portion 10 to function in its elastic range, and avoid
stress failure. Furthermore, the center section 14 provides a
virtual axis of rotation not necessarily centered at rod portion
10, thereby allowing the implant to more closely approximate the
normal physiology of the spine.
[0053] Referring now to FIG. 9, a separate embodiment of the
dynamic fixation device is illustrated. The dynamic fixation device
24 shown in FIG. 9 includes an inverted T-shaped spring within
central region 14. As with the dynamic fixation device 1 shown in
FIG. 3, first end 12 and second end 16 of rod portion 10 are
interconnected to connectors 18a and 18b, respectively, that are,
in turn, connected to pedicle screws 20 that are installed in the
pedicles of vertebrae. As with dynamic fixation device 1, the
connectors 18a and 18b used with dynamic fixation device 24 may be
formed as an integral part of the device 24, or they can be
separate, thereby providing adjustability at first end 12 and
second end 16. In addition to having a center section 14 that has a
relatively thin cross-section that can function in an elastic range
yet avoid stress failure as described above, the center section 14
has a shape that is non-linear, as depicted in FIG. 9.
[0054] Center section 14 preferably includes at least two bends,
and more preferably, a series of bends that add a further spring
effect. As noted above, rod portion 10 of the dynamic fixation
device 24 depicted in FIG. 9 includes an inverted T-shaped region
within center section 14. More particularly, dynamic fixation
device 24 includes a first pair of reverse bends 26a and 26b and a
second set of reverse bends 28a and 28b. Each reverse bend 26a,
26b, 28a, and 28b in the rod portion 10 is greater than about 90
degrees, and more preferably, each reverse bend is more than about
135 degrees and up to about 180 degrees. That is, rod portion 10
bends at bend 26a at least about 135 degrees and up to about 180
degrees before initiating bend 28a, which also bends at least about
135 degrees and up to about 180 degrees. Reverse bends 26b and 28b
are the opposite, but similar in curvature to the bends 26a and
28a, respectively.
[0055] The modified dynamic fixation device 24 shown in FIG. 9
helps dampen an axial compression load between the vertebrae
interconnected by the device. This construct not only allows for
bending between the vertebrae, but also provides a dampening effect
for compression loading that occurs between the vertebrae. The
inverted T-shaped region of center section 14 shifts the axis of
rotation forward, or anteriorly toward the physiologic axis. This
allows some axial loading of the spine without unduly stressing the
pedicle screw to bone interface.
[0056] Similar to dynamic fixation device 1, the center section 14
of dynamic fixation device 24 can have a variety of different
cross-sections. The center sections 14 shown in FIGS. 8a-8h present
a number of the possible cross-sections that can be used to
construct dynamic fixation device 24.
[0057] Referring now to FIG. 10, a separate embodiment of a dynamic
fixation device 30 is shown. Dynamic fixation device 30 features
the ability to provide a device that allows bending, as well as
dampening of compression loads, while at the same time providing
increased stability. Accordingly, depending upon a patient's
attributes, including physical size, age, bone density, and level
of activity, the device depicted in FIG. 10 may be more suitable
for certain patients.
[0058] The functional aspects of the dynamic fixation device 30 are
achieved by providing dual central members 32a and 32b. First
central member 32a includes an inverted T-shaped region similar to
that previously described, and as depicted in FIG. 9. In addition,
dynamic fixation device 30 features a second central member 32b
that is an arcuate shaped thin section.
[0059] The combination of two central members 32a and 32b maybe
modified in orientation depending upon the patient's needs. More
particularly, the arcuate shaped member may be positioned above
(not shown) the inverted T-shaped member or adjacent (not shown)
the T-shaped member, and not necessarily under the T-shaped member
as depicted in FIG. 10. Different orientations provide different
characteristics in bending and in compression, as well as in
torsion. Thus, various configurations of multiple member dynamic
fixation devices are appropriate for addressing specific patient's
needs, as the cases may dictate. Furthermore, two T-shaped members
in various orientations maybe used in contrast to one acuate member
and one inverted T-shaped member. Likewise, two acuate members may
also be used in combination, to include arcuate members stacked
like spoons, arcuate members oriented 180 degrees to each other, or
arcuate members disposed 90 degrees to each other.
[0060] For the embodiment depicted in FIG. 10, various
cross-sections for each central member 32a and 32b are possible.
Several, but not all possible cross-sectional views are depicted in
FIG. 11a-11f. Two elongated elliptical members are depicted in FIG.
11a. Alternately, central members 32a, 32b may take the form of one
elongated elliptical member and one flattened rectangle, as
depicted in FIG. 11b. In yet an alternate combination, a relatively
small circular member may be used in combination with a flattened
hexagonal member, as depicted in FIG. 11c. Alternately, a flattened
rectangular member may be used in combination with a bow tie-shaped
member, as depicted in FIG. 11d. Other combinations of shapes for
central members 32a and 32b not listed here are within the scope of
the invention.
[0061] In yet a separate embodiment, a dynamic fixation device can
utilize a coil portion (not shown) for providing a mechanism for
allowing the rod to bend. In an alternate design of this
embodiment, a composite material is used to serve as a bendable
portion. Whether a coil or composite material is used to form a
bendable portion, this embodiment preferably utilizes a mechanism
for preventing reverse bending, or posterior sagittal rotation. For
example, a separate stiffener may be provided on the posterior side
of the coil portion, thereby allowing the device to bend in a
forward direction, allowing anterior sagittal rotation, but
substantially limiting or preventing bending in a reverse
direction, thereby preventing posterior sagittal rotation.
Furthermore, multiple stiffeners may be used to limit lateral
rotation. That is, additional stiffeners may be incorporated that
substantially limit or prevent left or right coronal rotation.
[0062] The nature of the coil may be a single winding, a double
winding, or it may contain a plurality of windings. In one
preferred embodiment, a helix-shaped coil is provided. Coils uncoil
when stressed. Composites have physical properties that mimic
coiling and uncoiling depending upon the loading conditions. Coils
may be used in combination with composite materials, and in
combination with stiffeners of various orientations.
[0063] In a typical use to span two vertebra, the total length of
the dynamic fixation devices 1, 24, and 30 may be approximately 25
to 30 mm. For a dynamic fixation device spanning one joint, it will
expand up to approximately 5 to 10 mm in length, and will rotate
forward up to between 5 to 10 degrees to accommodate flexion of the
spine. Obviously, different size dynamic fixation devices may be
used to accommodate the specific needs of each individual patient.
More particularly, a relatively large dynamic fixation device may
be needed for a large man, while a relatively small dynamic
fixation device may be needed for a smaller patient, such as child
or a petite woman. However, a limited number of sizes may provide
adequate coverage for the majority of the patient population. For
any given device, a potential elongation of the dynamic fixation
device of approximately 20% is anticipated.
[0064] The dynamic fixation devices can be used to flexibly fuse a
plurality of vertebra. Alternatively, the dynamic fixation devices
can be located at specific points where bending of the spine is
desired, while a rigid rod may be used at other locations desired
by the physician.
[0065] The structures of the present invention are made from one or
more materials that possesses the appropriate strength
characteristics necessary to withstand loading from the human body
when used in medical applications. In addition, the materials are
compatible with the human body. Preferably, materials include
ceramics, plastics, metals, or carbon fiber composites. More
preferably, the materials are made from titanium, a titanium alloy,
or stainless steel.
[0066] Devices disclosed herein can also be made of thermal memory
materials or materials that possess different elastic properties at
varying temperatures. In this aspect of the invention, the subject
component(s) may be heated or cooled to a desired temperature,
implanted, then subsequently allowed to cool or warm to the
temperature of the ambient conditions that will exist during the
usage period for the subject device, namely, normal body
temperature.
[0067] It is to be understood that the present invention has
application to medical devices other than spinal implants.
Furthermore, it is understood that the present invention has
application outside the medical field. The dynamic fixation device
of the present invention is not limited to medical implants. The
device could be used in seismic dampening applications.
Alternatively, the present invention could be used to secure any
two objects, such as in linking mechanisms, and has application to
any type of mechanical device with a moving connection. Other
applications, by no means exhaustive, may include connecting any
articulated device, such as an implement connection to a tractor.
It may also be used in heretofore static type connection
applications, such as attaching an antenna to a base structure. One
of skill in various of the construction arts will appreciate how to
make and use the present invention in view of the guidance provided
herein (with respect to a surgical application) and in view of the
figures set forth herein.
[0068] While various embodiments of the present invention have been
described in detail, it is apparent that modifications and
adaptations of those embodiments will occur to those skilled in the
art. However, it is to be expressly understood that such
modifications and adaptations are within the spirit and scope of
the present invention, as set forth in the following claims.
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